Iso-Gard Hepa Filter-Hme, Iso-Ard Hepa Filter-Hme W/Port
FDA 510(k) K954828 · Gibeck, Inc.
510(k) numberK954828
Submission
- Device name
- Iso-Gard Hepa Filter-Hme, Iso-Ard Hepa Filter-Hme W/Port
- Applicant
- Gibeck, Inc.
Indianapolis, IN, US - Received
- October 20, 1995
- Decision date
- May 2, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAH – Filter, Bacterial, Breathing-Circuit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5260
- Specialty
- Anesthesiology
Other 510(k)s with product code CAH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledCAH · Traditional | Teleflex Medical Sdn. Bhd. | 05/15/2026SE |
| K251583 | Ambu® Virobac II® Exhalation FilterCAH · Traditional | Ambu A/S | 04/30/2026SE |
| K241339 | Besmed Bacterial Filter and HMEFCAH · Traditional | Besmed Health Business Corp | 11/14/2024SE |
| K222917 | Breathing circuit bacterial/viral filterCAH · Traditional | Shaoxing Haitech Medical Products Co., Ltd. | 02/15/2024SE |
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)CAH · Traditional | Passy-Muir, Inc. | 09/16/2023SE |
| K223258 | TNI Clear-Guard 3 angled breathing filter (1545020)CAH · Traditional | Intersurgical , Ltd. | 06/15/2023SE |
| K221472 | Filter and HME/FilterCAH · Traditional | Ningbo Huakun Medical Equipment Co., Ltd. | 02/08/2023SE |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusCAH · Traditional | Drägerwerk AG & Co. KGaA | 12/07/2022SE |
| K221250 | EasyOne FilterCAH · Traditional | Ndd Medizintechnik AG | 11/22/2022SE |
| K210352 | GGM Breathing Circuit Bacterial FilterCAH · Traditional | Great Group Medical Co, Ltd. | 03/27/2022SE |
More from Great Group Medical Co, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K965016 | Iso-Gard Filter ANGLED(18212)/ISO-GARD Filter STRAIGHT(19212)CAH · Traditional | 12/02/1997SE |
| K964377 | Thermal Regulation System BlanketDWJ · Traditional | 04/23/1997SE |
| K964382 | Humid-Vent Filter Compact Angled (18402)/HUMID-VENT Filter Compact STRAIGHT(19402)CAH · Traditional | 04/15/1997SE |
| K960511 | Gibeck Warmbag Reusable Convective Warming BlanketDWJ · Traditional | 01/13/1997SE |
| K953544 | Humid-Vent 2 Light/Humid-Vent 2 Port LightBYD · Traditional | 08/25/1995SE |
| K953491 | Humid-Vent 1 Port/Humid-Vent 1 Port AngleBYD · Traditional | 08/25/1995SE |
| K952845 | Humid-Vent Trach-VentBYD · Traditional | 07/25/1995SE |
| K952844 | Humid-Vent 2BYD · Traditional | 07/20/1995SE |
| K952750 | Humid-Vent 1BYD · Traditional | 07/20/1995SE |
| K952084 | Humid-Vent Filter PediBYD · Traditional | 06/12/1995SE |
Questions and answers
When was Iso-Gard Hepa Filter-Hme, Iso-Ard Hepa Filter-Hme W/Port cleared by the FDA?
Iso-Gard Hepa Filter-Hme, Iso-Ard Hepa Filter-Hme W/Port (K954828) received a 510(k) decision of Substantially Equivalent on May 2, 1996, 195 days after the submission was received.
What is the product code of K954828?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.